Obesity Clinical Trial
Official title:
The Influence of Reducing Diets on Changes in Thyroid Parameters in Women Suffering From Obesity and Hashimoto's Disease
Verified date | February 2021 |
Source | Medical University of Bialystok |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hashimoto's disease is listed among the most common endocrine causes of obesity. As treatment of obesity in women with Hashimoto's disease is frequently unsuccessful, the aim of this study was to evaluate the effectiveness of two different reducing diets and their influence on changes in thyroid parameters in the female patients. A six-month observational/interventional study was performed on 100 women aged 18-65 years, previously diagnosed with Hashimoto's disease and obesity and receiving L-thyroxine. The women were randomly assigned to the test group (group A, n=50) following elimination/reducing diets, and the control group (group B, n=50) following reducing diets with the same caloric content (without elimination). Anthropometric and thyroid parameters were evaluated at the beginning, after 3 months and after 6 months of treatment.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 31, 2019 |
Est. primary completion date | April 19, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Diagnosed with Hashimoto's disease - BMI over 30 kg/m2 - Taking the L-thyroxine, 200 mcg of 1-selenomethionine/day, and 30 mg of zinc gluconate/day throughout the study period Exclusion Criteria: --- |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Dietetic and Clinical Nutrition; Medical University of Bialystok | Bialystok |
Lead Sponsor | Collaborator |
---|---|
Medical University of Bialystok |
Poland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients from obesity and Hashimoto's disease. | The body weight (kg) was measured using a scale with a stadiometer. | This measurement was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients suffering from obesity and Hashimoto's disease. | The height (cm) was measured using a scale with a stadiometer. This measurement is needed to calculate the Body Mass Index. | This measurement was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on Body Mass Index changes in patients suffering from obesity and Hashimoto's disease. | Body Mass Index (kg/m^2) was calculated from the measurements of height and weight using a mathematical formula. | This measurement was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in muscle mass in patients suffering from obesity and Hashimoto's disease. | Muscle mass (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan). | This measurement was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in total body water in patients suffering from obesity and Hashimoto's disease. | Total body water (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan). | This measurement was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in percent body fat in patients suffering from obesity and Hashimoto's disease. | Percent body fat (%) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan). | This measurement was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in thyroid parameters in patients suffering from obesity and Hashimoto's disease. | Laboratory tests were performed to determine the following serum levels: TSH, fT3, fT4, anti-TPO, and anti-TG. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast. | This examination was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in glucose blood level in patients suffering from obesity and Hashimoto's disease. | Laboratory tests were performed to determine glucose blood level. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast. | This examination was repeated during 3 visits every 12 weeks. | |
Primary | Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in lipid profile in patients suffering from obesity and Hashimoto's disease. | Laboratory tests were performed to determine the lipid profile: total cholesterol, high-density lipoprotein (HDL), low-density (LDL) cholesterol and triglycerides. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast. | This examination was repeated during 3 visits every 12 weeks. |
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